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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
In Vitro Diagnostic Multivariate Index Assays - Draft Guidance for Industry, Clinical Laboratories, and FDA Staff  Food and Drug Administration (FDA) Proposed
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Guidance for Industry  Food and Drug Administration (FDA) Proposed
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Innovative Approaches for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Insanitary Conditions at Compounding Facilities Guidance for Industry  Food and Drug Administration (FDA) Proposed
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators  Food and Drug Administration (FDA) Proposed
Labeling for Combined Hormonal Contraceptives Guidance for Industry  Food and Drug Administration (FDA) Proposed
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